A Procedure for Developing Quantitative Near Infrared (NIR) Methods for Pharmaceutical Products
The pharmaceutical industry uses procedures to describe all the instructions needed to perform a process in a consistent manner. Procedures are based on process knowledge and the desire to consistently meet desired specifications. This chapter proposes a
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Introduction Pharmaceutical engineers are likely to be part of a process development team that includes one or more analytical methods that involve near infrared spectroscopy (NIRS). The identity test of incoming raw materials and active pharmaceutical ingredient in a new product could be performed with NIRS. NIRS is an effective and proven technique to identify incoming raw materials and meet the 21CFR 211.184 cGMP requirements that “At least one test shall be conducted to verify the identity of each component of a drug product.” NIRS is considered an established method for identity testing [1] but is also capable of providing valuable information for pharmaceutical processes. The adoption of NIRS by the pharmaceutical industry has continued to grow to include monitoring the drying of an active pharmaceutical ingredient or a formulation following wet
Marianthi G. Ierapetritou and Rohit Ramachandran (eds.), Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture, Methods in Pharmacology and Toxicology, DOI 10.1007/978-1-4939-2996-2_5, © Springer Science+Business Media New York 2016
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granulation [2–4]. NIRS could be used to monitor and evaluate the adequacy of mixing for a pharmaceutical formulation [5, 6], and drug concentration in the final product. The numerous applications of NIR spectroscopy are not limited to analytical methods required by regulatory agencies, and also include process understanding and troubleshooting [7, 8]. Thus, an understanding of the current state of NIR spectroscopy is useful for the pharmaceutical engineers involved in process development teams and to the regulatory agencies that evaluate NIR methods developed by industrial scientists. The main motivations for the adoption of NIRS methods is the analysis of samples in their native “as is” condition in the manufacturing area without the need to dissolve the sample in a solvent and the need to transport the sample to the QC laboratory. Traditional Quality Control (QC) analytical methods are usually characterized by sample preparations that involve extraction of an analyte to a solvent, filtration and centrifugation steps to transform a tablet or other pharmaceutical product into a clear solution. Sample preparation accounts for at least 50 % of the analysis time in the traditional QC lab. The traditional analytical methods also require removing the material from the manufacturing site and transport to the QC lab. This grab sampling involves a significant risk that the sample brought to the lab is not representative of the production process, and it is estimated that the sampling error is much greater than the analytical method error [9–11]. NIR spectrometers have been interfaced with manufacturing equipment providing real time measurements that may be used to monitor the production process [2–6]. A NIR spectrum with a high signal to noise ratio may be obtained in as little as 100 ms, but could require 1 min in some applications such as transmission spectra of tablets. NI
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